July 25, 2012 — After the U.S. Food and Drug Administration (FDA) found “significant objectionable conditions” at Sanofi vaccine plants in Canada and France, the agency is asking for a meeting with senior executives at the drug company. FDA inspectors found 24 violations of good manufacturing practices at the Toronto, Canada facility, and two violations at a plant in Marcy I’Etoile, France.
The FDA found serious mold and contamination issues at the Toronto facility, and now regulators say this will lead to a shortage of Bacillus Calmette-Guerin (BCG) tuberculosis vaccines. According to the FDA, since August 2010, “there have been no less than 58 documented non-conformances related to the isolation of mold within the BCG aseptic processing areas.”
The agency has called for a meeting with Olivier Charmeil, Sanofi’s head of vaccines, and other senior executives. The agency is ordering a “comprehensive and global assessment of all its manufacturing operations to ensure that all products conform to FDA requirements.” Sanofi has stated that they are taking steps to address the FDA’s comments and they have confidence in the products manufactured at the plants.
Last month, Sanofi voluntarily recalled four batches of BCG tuberculosis vaccines due to sterility problems. The vaccines were recalled in Australia, Canada, and New Zealand. Manufacturing was suspended at the Toronto facility to improve manufacturing operations and quality systems. This will cause a shortage of the BCG vaccine in Australia and possibly Canada. It is also possible that a halt in production will also cause a global shortage of other drugs, but company spokesmen say that the shutdown will not affect other drugs.
The last successful sterility test at the Toronto facility was in 2000. In the FDA warning letter, the agency was concerned that Sanofi could not be sure that all lots of the BCG vaccine were safe. The FDA was also concerned that Sanofi was not using a quality-control test capable of detecting mold in the product.
In addition to mold contamination, the FDA was also concerned about other sterility issues. There were nesting birds in the air handling units, and inadequate separation between the washing area and the live vaccine area. Furthermore, French Sanofi investigators failed to determine the reason why some lots of typhoid vaccines and Conjugated Haemophilus vaccine failed quality-control tests.
The FDA also noted that warning letters are reviewed by federal agencies to inform decisions about whether to renew contracts with vaccine manufacturers. Sanofi Pasteur is the largest pharmaceutical company that creates human vaccines in the world.
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